Ridgeback begins enrolment for phase 2 Covid-19 trial of EIDD-2801
Ridgeback Biotherapeutics announces the start of enrollment in a Phase 2 trial of potential COVID-19 treatment EIDD-2801. The new trial will be conducted using the new COVID-19 drug testing platform AGILE, which was developed by The University of Liverpool, Liverpool School of Tropical Medicine and Southampton Clinical Trials Unit. AGILE will test multiple potential therapeutics, and EIDD-2801 was selected to be the first oral anti-viral to be studied in the AGILE platform.
“Ridgeback is proud to work with Professor Saye Khoo, Chief Investigator on AGILE at the University of Liverpool and his team to design the EIDD-2801 specific protocol,” said Wendy Holman, co-founder and CEO of Ridgeback Biotherapeutics. “It was a tremendous trans-continental effort to bring EIDD-2801 into a Phase 2 efficacy protocol to benefit COVID-19 patients in the U.K. immediately following Phase 1. Ridgeback is especially appreciative of the rapid and intensive input and guidance from MHRA throughout this process.”
Due to COVID-19, many Phase 1 sites were closed to all activity and others were limited to only test COVID-19 related therapeutics during March, April and May. Through April and May, Ridgeback was able to conduct stream-lined Phase 1 trials, condensing 12 to 18 months of work into just two months. This accelerated development was made possible because of the dedicated efforts of the Ridgeback team, FDA, MHRA and Ridgeback’s CRO, Covance.
Ridgeback’s accelerated Phase 1 trials ensure that tests of EIDD-2801 will not be delayed now that Phase 1 sites are reopening across the U.S., allowing medicines for other therapeutic areas to be trialed.
Ridgeback announced last week the closing of its collaboration agreement with Merck, known as MSD outside the United States and Canada. Results from this upcoming AGILE study, as well as two previously initiated Phase 2 studies in the U.S., will provide valuable information as Merck, in collaboration with Ridgeback, plans further clinical trials in patients with COVID-19. Ridgeback and Merck are committed to making the medicine accessible and affordable globally.